Spine BioPharma’s randomised Phase III MODEL trial assessing the transforming growth factor beta (TGF-β) antagonist, SB-01, failed to achieve its primary goal of pain intensity and function related to pain related to degenerative disc disease (DDD) at six months after the treatment, compared to a sham control.
The multi-centre, double-blind, placebo-controlled US trial focused on establishing the effectiveness and safety of the therapy as an intradiscal treatment for adults with chronic low back pain (CLBP) associated with due to lumbar DDD.
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It involved 417 subjects who received one 1.5ml intradiscal injection of the therapy or a sham control. The one- and two-level DDD subjects were enrolled across 30 US sites.
The subjects were evaluated at various timepoints up to the primary endpoint at six months, with a further follow-up period at 12 months.
Assessments included pain intensity using the Numerical Rating Scale (NRS) and function related to pain using the Oswestry Disability Index (ODI).
Despite not meeting the primary endpoint, the SB-01 group claims to have seen a numerical improvement in pain-related function and intensity.
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By GlobalDataThe safety profile was found to be consistent with the earlier Phase II trial, and the treatment response was durable at one year.
The company noted that no difference was observed in success between subjects with one and two levels of DDD.
To be considered an overall composite success, which was the primary endpoint of the trial, subjects had to achieve a 15/100-point and a 2/10-point improvement in ODI and NRS scores, respectively.
The trial’s intent-to-treat (ITT) analysis showed that 67% of the therapy group achieved primary endpoint success at six months, and 62% met composite success at 12 months.
Despite this, these results did not reach statistical significance when compared to the sham control group.
A secondary endpoint analysis of pain-related function revealed a 75% success rate at six months and 71% at 12 months for the SB-01 group, which was also not statistically significant.
Spine BioPharma CEO Marc Viscogliosi said: “Despite our disappointment in missing the primary endpoint, we are quite proud of enrolling and completing this trial under strict FDA guidelines.
“We ran a solid trial and, had we achieved our anticipated sham control group response, the results would have been statistically significant in favour of SB-01.”
The company is set to conclude the analysis of the data and engage with the Food and Drug Administration (FDA) to discuss the trial outcomes and explore potential approval pathways for the therapy as a treatment for CLBP associated with moderate-severe DDD.
